A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
Post-transition: Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020. This webinar was part of a series of EU Exit and post-transition guidance webinars.
The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity
The BPC is looking to appoint a new Chair from October 2021. The current Chair, Professor Kevin Taylor, shares some of the highlights and achievements of the past 8 years, and we launch the process of finding his successor.
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.
Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations. We share some common issues seen at inspections so you can consider your own company’s systems and practices and improve investigation outcomes.
During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities.
A look at the Serious Breach data for 2019 plus details of update to the notification form and guidance documents
On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic